MAUDE Adverse Event Report: Medline Industries, LP CENTURION; YNHH ARTERIAL LINE INSERTION TRAY

Catalog Number	ART685
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the adapter/connector in the arterial line bundle malfunctioned.The lumen in the connector is not patent.".
Additional Manufacturer Narrative
The customer contact reported the adapter/connector in the arterial line bundle malfunctioned and the lumen in the connector is not patent; no medical intervention, serious injury, or follow-up care has been reported.Since the product lot number was unknown and a sample was not returned, the investigation was limited; a review of centurion's complaint history found two reports of the adapter malfunctioning, which were reported concurrently, and the report was forwarded to the vendor for notification of the issue.The reported problem was an unconfirmed defect and a root cause could not be determined.Based on this information, the incident appears to occur infrequently, and the division will continue to monitor this issue and will initiate corrective actions if a trend is identified.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: CENTURION
• Common Device Name: YNHH ARTERIAL LINE INSERTION TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50852933
• Report Number: 1417592-2026-47288
• Device Sequence Number: 15940913
• Product Code: LRO
• UDI-Device Identifier: 00653160361827
• UDI-Public: 00653160361827
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ART685
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown